Kornimate/medical-research-clean huggingface dataset:
nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy for locally advanced pancreatic adenocarcinoma

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Summary: the study is a prospective and observational cohort study. the purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (pdac)

we will prospectively collect 100 patients who receive nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy or nab-paclitaxel and gemcitabine alone. data will be stored in a private database. the process of data collection will be supervised and regular data examination will be performed.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 years; 2. histologically or cytologically proven diagnosis of pancreatic adenocarcinoma; 3. treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the national comprehensive cancer network definitions); 4. no distant metastasis as defined by ct or mri of the chest, abdomen and pelvis; 5. at least 1 measurable lesion based on the response evaluation criteria in solid tumors criteria (recist) 1.1; 6. an eastern cooperative oncology group (ecog) performance status score of 0 to 1; 7. adequate hematological, liver, renal function: 1. absolute neutrophil count≥1500 cell/mm3; 2. platelet count≥100×109/l; 3. hemoglobin concentration \>90 g/l; 4. albumin≥30 g/l ; 5. total bilirubin\<1.5 times the upper limit of normal; 6. alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal; 7. serum creatinine concentration\<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 ml/min; 8. life expectancy of at least 3 months. exclusion criteria: 1. with any other malignancy within the 5 years before enrolment; 2. with active infections (bacterial, viral, or fungal) requiring systematic treatment, with hepatitis b or c infection, or a history of hiv infection, or receiving immunosuppressive therapy; 3. with peripheral sensory neuropathy at a grade \>1; 4. with a history of allergy or hypersensitivity to the study drugs; 5. pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.
mobile microwave-based diagnosis and monitoring of stroke

Conditions: Stroke, Acute; Intracerebral Hemorrhage

Summary: this is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for ct scan. the study assesses the diagnostic capability and safety of strokefinder md100.

this is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for ct scan. the investigator will assess and control the inclusion/exclusion criteria. if the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. if the answer is affirmative the microwave measurement will be performed. the procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. the measurement data will be evaluated for the presence of signal artifacts. the diagnostic ability of the device will be evaluated using a leave-one-out cross validation (loocv) method with the ct diagnosis as ground truth. safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. no further follow-up of patients is planned.

Eligibility criteria:
inclusion criteria: * patient with clinical signs of stroke * patient should be ≥ 18 years of age * patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase) * signed informed consent form (after acute phase) exclusion criteria: * pregnant or nursing woman * fertile woman where pregnancy cannot be excluded * patient diagnosed with a condition associated with risk of poor protocol compliance * the diagnostic procedure is deemed to interfere with the standard of care * any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment * any patient that according to the declaration of helsinki is deemed unsuitable for study enrolment
platelet-rich plasma intradermal injection combined with 308 nm excimer light for treating stable acral vitiligo

Conditions: Vitiligo

Summary: the goal of this clinical trial is to learn if platelet-rich plasma (prp) works to treat acral stable vitiligo in adults. it will also learn about the safety of platelet-rich plasma. the main questions it aims to answer are: * does prp combined with 308 nm excimer phototherapy improve the efficacy compared to 308 nm excimer light alone in the treatment of vitiligo of the extremities? * what medical problems do participants have when taking prp intradermal injections? researchers will compare prp to a placebo (a look-alike substance that contains no drug) to see if prp works to treat acral vitiligo. participants will: * receive prp intradermal injections once a month and 308 nm excimer phototherapy twice a week, or the same frequency of saline injections and phototherapy for 6 consecutive months * visit the clinic once every 1 month for evaluations * keep a diary of their symptoms or side effects during follow-up

vitiligo is an acquired skin disorder characterized by depigmented macules, and one of the conventional treatment principles is to promote the differentiation of stem cells at the follicular bulge into melanocytes, but vitiligo of the extremities is clinically difficult to repigmentation and resistant to treatment due to its lack of hair follicles. platelet-rich plasma (prp) is a concentrated platelet plasma obtained by in vitro isolation of autologous whole blood, and its effect on repigmentation of vitiligo at the extremities and the potential mechanism remain unclear. the investigators investigated the efficacy of prp on acral vitiligo by a single-center, prospective, self-controlled clinical study.

Eligibility criteria:
inclusion criteria: * patients with non-segmental vitiligo stable for more than half a year; * at least 1 separate stable lesion on each of the dorsum of the right and left hands, proximal fingers, distal fingers and palms; * the area of white spots is less than 10 % of the total body surface area and more than 1 % of the total body surface area; * those who have not received systemic treatment of vitiligo and phototherapy or related treatments within 1 month ≥ 1 year without significant efficacy; * voluntary signing of informed consent. exclusion criteria: * pregnant and lactating women; * those who have used glucocorticoids or other immunosuppressants in the last 3 months; * suffering from haematological disorders such as coagulation abnormalities and thrombocytopoietic disorders; * those who are allergic to ultraviolet light and photosensitive treatment; * scar constitution; * those with current or previous history of skin cancer or family history of skin cancer; * those with infectious diseases such as hiv, syphilis, hepatitis b or c; * those with other serious systemic diseases; * patients who, in the judgement of the investigator, are not suitable for inclusion in this trial.

Keywords: acral vitiligo platelet-rich plasma 308 nm excimer light
a study to evaluate the effects of giving proleukin (ril-2) to hiv-positive patients with cd4 counts greater than 300 cells/mm3

Conditions: HIV Infections

Summary: the purpose of this study is to examine how ril-2 affects hiv-positive patients with cd4 counts over 300 cells/mm3 who are on anti-hiv drug therapy. the drug ril-2 has been shown to increase cd4 cell counts, which help the body fight off hiv. there is strong evidence that ril-2 increases cd4 cell counts (cells of the immune system that fight infection). this study examines the effect of 2 different amounts of ril-2 on cd4 cell count and the amount of hiv in the blood (viral burden).

there is substantial evidence that ril-2 increases cd4+ cell count. whether or not ril-2 delays progression to aids and extends survival is currently unknown, such clinical benefits of ril-2 can only be established in a large, long-term, randomized trial. this study examines the effect of two different ril-2 doses on hiv viral burden and cd4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of ril-2. patients are randomized to receive one of two subcutaneous (sc) doses of recombinant ril-2 or no ril-2. those patients who take ril-2 initially receive three courses of treatment. for this study, a course is defined as eight calendar weeks, including the five-day period of sc ril-2 administration. additional courses are given (no more frequently than every 6 weeks) in order to maintain a cd4+ count of at least twice its baseline level or at least 1,000 cells/mm3. follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * agree to practice abstinence or use effective birth control methods during the study. * are on anti-hiv therapy and have a cd4 count of at least 300 cells/mm3. * are at least 18 years old. exclusion criteria you will not be eligible for this study if you: * have a history of progressive diseases. * have a history of severe autoimmune/inflammatory disease. * have crohn's disease. * are taking antiseizure medications or certain other medications. * are receiving chemotherapy. * are pregnant or breast-feeding. * have ever received ril-2.

Keywords: aids-related opportunistic infections interleukin-2 dose-response relationship, drug adolescent behavior cd4 lymphocyte count rna, viral quality of life anti-hiv agents viral load
the hiv functional cure potential of ub-421 in art stabilized hiv-1 patients

Conditions: HIV-1-infection

Summary: this is a phase ii, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of ub-421 administered as an add-on to the standard art in art-treated hiv-1 subjects with stably suppressed hiv-1 plasma vl. the study will be conducted at multiple study centers, designated aids hospitals in china.


Eligibility criteria:
inclusion criteria: 1. hiv-1 sero-positive 2. male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. 3. hiv-1 plasma rna level below 50 rna copies/ml. exclusion criteria: 1. subjects with active systemic infections, except for hiv-1, that the investigator feels the infections may confound evaluation and treatment for hiv-1. 2. current active hepatitis b carriers, ie, hepatitis b surface antigen positive. 3. current active hepatitis c carriers, ie, hepatitis c virus (hcv) antibody positive. 4. history of anaphylaxis to other mabs. 5. any vaccination within 8 weeks prior to the first dose of assigned drug. 6. use of immunomodulators, hiv vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug. 7. females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
prediction of immediate postoperative pain using analgesia/nociception index (ani)

Conditions: Postoperative Pain

Summary: the aim of this study is to evaluate the performance of analgesia/nociception index (ani) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.

assessment of the performance of ani to predict immediate postoperative pain on a 0-10 numerical rating scale (nrs) \>3 by building a receiver operating characteristic curve.

Eligibility criteria:
inclusion criteria: * adult * ear-nose-throat or orthopedic surgical procedures * halogenated and remifentanil-based general anesthesia exclusion criteria: * age \ 75 yrs * arrythmia * administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes * psychiatric diseases * autonomic nervous system disorders (epilepsy) * inability to understand the verbal rating pain scale

Keywords: analgesia nociception index ani
a user performance and system use evaluation of a new blood glucose monitoring system ( bgms)

Conditions: Diabetes Mellitus

Summary: this study is the us regulatory clinical evaluation - user performance and system use evaluation of a new blood glucose monitoring system (bgms).

user performance - assess lay user fingertip test results obtained on the new bgms compared to a validated method (ysi 2300 stat plus glucose analyzer results) according to fda guidance 2016 section vi.c. assess system use of the new bgms, as relevant to self-testing technique, with reference to the owner's booklet.

Eligibility criteria:
summary of inclusion criteria: subject is at least 12 years old. informed consent. subject has a current diagnosis of type 1 or type 2 diabetes mellitus. subject reads and understands english. subject is currently performing unassisted self-monitoring of blood glucose (smbg) or naive to smbg for a 10% sub-group. summary of exclusion criteria: conflict of interest. technical expertise.
ncle for diagnosis of peripheral lung nodules by robotic navigational bronchoscopy

Conditions: Diagnosis of Peripheral Lung Nodules

Summary: needle based confocal laser endomicroscopy (ncle) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. with resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (wijmans, et al., 2019). the effectiveness of ncle with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (wijmans, et al., 2019). in this study, the proposed ncle lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. probe based confocal microscopy (pcle) has also been used in conjunction with a radial probe ebus in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (hassan, et al., 2017) needle based confocal laser endomicroscopy (ncle) has not previously been used in conjunction with robotic navigational bronchoscopy.


Eligibility criteria:
inclusion criteria: * men and women, regardless of race, ethnic group or sexual orientation are eligible for this study. * patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm * age \> 18 years. * patients must have normal organ and marrow functions as defined below: leukocytes \> 3,000/mcl absolute neutrophil count \> 1,500/mcl total bilirubin within normal institutional limits hemoglobin ≥7.0 ast/alt (sgot/sgpt) \ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal * ability to understand and willingness to sign a written informed consent and hipaa consent document * wocbp must agree not to get pregnant until after the day of the procedure exclusion criteria: * patients with uncorrectable coagulopathy will be excluded. * known allergy to fluorescein or other contrast media * patients with hemodynamic instability will be excluded * patients with refractory hypoxemia will be excluded * patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure * patients who are unable to tolerate general anesthesia according to the anesthesiologist * patient requires chemotherapy * pregnant or breast feeding. refer to section 4.5 for further detail. * subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study * pregnancy: women of child-bearing potential (wocbp) who are pregnant on the day of the procedure will be excluded from the study.
methoxyflurane and fentanyl in lbnp

Conditions: Hypovolemia; Cardiac Output, Low; Analgesia

Summary: the study is a single-centre, placebo-controlled, crossover study on healthy volunteers aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the tolerance to hypovolemia.

the study will explore the effects of fentanyl and methoxyflurane versus placebo (nacl; saline) on the hemodynamic response to hypovolemia in healty volunteers. hypovolemia will be induced in the "lower body negative pressure" model. xx healthy volunteers will be exposed to inhaled methoxyflurane, 3 ml or intravenous fentanyl, xx mg or placebo in a randomized order (cross-over) at least 3 days apart.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age. * must be below 65 years of age. * signed informed consent and expected cooperation for the study and follow up must be obtained and documented according to ich gcp, and national/local regulations. exclusion criteria: * any medical condition limiting physical excertional capacity or requiring regular medication (allergy and oral contraceptives excepted) * pregnancy * history of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted) * any known cardiac arrhythmia * history of renal disease * history of liver disease * previous substance abuse * allery or known serious side-effects to opioids or methoxyflurane

Keywords: methoxyflurane fentanyl
n-force screws augmented with n-force blue in hip fractures

Conditions: Intracapsular Proximal Femur Fracture; Garden Grade I Subcapital Fracture of Femoral Neck; Garden Grade II Subcapital Fracture of Femoral Neck

Summary: the objective of this prospective study is to confirm safety and performance of n-force screws augmented with n-force blue applied in intracapsular proximal femur fracture treatment.

primary endpoint: • re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. secondary endpoints: * radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction. * cost effectiveness

Eligibility criteria:
inclusion criteria: * patient has primary garden i or ii intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with n-force blue. * patient receives operative treatment within 7 days of injury. * patient was ambulatory before injury. * patient is 50 years of age or older. exclusion criteria: * patient has garden iii or iv intracapsular proximal femur fracture. * patient has major cognitive impairment (including dementia). * patient is on dialysis. * patient is not expected to survive follow-up schedule. * patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (investigator's discretion). * patient is a prisoner. * patient is known to be pregnant and/or breastfeeding. * patient is a known alcohol or drug abuser. * patient had previous/has active acute or chronic infections, especially at the site of operation. * patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant. * patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected. * patient is expected to be non-compliant with recommended post-operative weight-bearing instructions. * physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.

Keywords: cannulated screws augmentation
microparticles in obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is independently associated with cardiovascular diseases, including myocardial infarction and stroke. osa may promote atherosclerosis risk factors such as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the vascular wall. a growing number of studies have recently focused on the role of microparticles (mps) in the atherogenic process. case-control studies have shown that platelet-, endothelial- and leukocyte-derived mp levels are increased in osa and that leukocyte-derived mp are released during the night in osa. furthermore, experimental evidence shows that mps from osa patients induce endothelial dysfunction. the objective of this prospective study is to evaluate the impact of increased levels of leukocyte derived mps on the cardiovascular outcomes in patients with prevalent cardiovascular diseases investigated for osa.

mps are small plasma membrane vesicles that can be released by a variety of vascular or blood cells and that contain membrane and cytosolic elements. case-control studies have shown that platelet-, endothelial- and leukocyte-derived mp levels are increased in osa. experimental evidence shows that mps from osa patients induce endothelial dysfunction, inflammation, and vascular hyperreactivity when injected to mice. the impact of increased levels of mps on the cardiovascular prognosis in osa patient with prevalent cardiovascular diseases in unknown.

Eligibility criteria:
inclusion criteria: * diagnosis of coronary artery disease or cerebrovascular disease * diagnosis of moderate-to-severe osa exclusion criteria: * pregnancy * previously treated osa

Keywords: microparticles cardiovascular outcomes